We are currently hiring for a Lead Design Engineer - PAS-X MES position with our client LTTS. This is a great opportunity for candidates with strong hands-on experience in PAS-X MES design, validation, and manufacturing system integration within regulated environments.
Position Details
Role: Lead Design Engineer - PAS-X MES
Location: Duluth, Georgia (Onsite/Hybrid - as per client requirements)
Key Responsibilities
- Design, configure, and maintain Master Batch Records (MBRs), master data, workflows, and business logic in PAS-X v2
- Support and troubleshoot PAS-X integrations with ERP (SAP), LIMS, PLC/SCADA, and other shop-floor or enterprise systems
- Provide L2/L3 production support, including incident resolution, root-cause analysis, and execution of change management activities
- Actively participate in system validation efforts, including preparation and execution of URS, FRS, IQ, OQ, and PQ
- Ensure systems comply with GAMP 5, 21 CFR Part 11, and EU Annex 11 regulatory requirements
- Work closely with Manufacturing, Quality Assurance, and IT teams to support production and continuous improvement initiatives
- Support documentation, audit readiness, and regulatory inspections as required
Required Qualifications
- Bachelor's or Master's degree in Instrumentation & Control, Electronics, Computer Engineering, or a related discipline
- Strong hands-on experience with PAS-X MES (v2 preferred) in Pharma, Biotech, or Life Sciences environments
- Solid understanding of MES validation, compliance standards, and SDLC in regulated industries
- Experience working in cross-functional, global teams
Nice to Have
- Experience with SAP MES integrations
- Prior exposure to manufacturing execution systems support in production environments
- Familiarity with CSV documentation and audit support